Janssen's potential "first-in-class" bispecific antibody is clinically approved in China

Text|Pharmaceutical Mission Hills

The Center for Drug Evaluation (CDE) of the National Medical Products Administration of China revealed that the Class 1 new drug, talquetamab injection, declared by Johnson & Johnson's Janssen company, has obtained the implied license for clinical trials and is intended to be developed for multiple bone marrow.

Screenshot source: CDE official website

GPRC5D (G protein coupled receptor C5 family subtype D) is an innovative multiple myeloma target, which is highly expressed in multiple myeloma cells and is associated with poor prognostic factors

At the 2020 American Society of Hematology (ASH) annual meeting, Janssen announced the results of a phase 1 clinical trial of valvetamab in the treatment of patients with multiple myeloma, showing that both subcutaneous injection and intravenous infusion of valvetamab showed promising clinical activity

At the 2021 American Society of Clinical Oncology (ASCO) annual meeting, Janssen once again announced the follow-up data of the first phase 1 human dose escalation study (MonumenTAL-1) of talentamab

These new and updated efficacy and safety data indicate that talentamab is a promising treatment candidate for patients with multiple myeloma who have relapsed after multiple treatments or have not responded to other treatments

The two approvals of the talentamab in China this time also means that Janssen is about to carry out clinical studies of this innovative double antibody in China

Reference materials:

[1] Drug Evaluation Center of China National Medical Products Administration.

[2] Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma.

[3] Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma.